Revenue: As of FY2026 Q1, the actual value is USD 215.39 M, missing the estimate of USD 220.84 M.EPS: As of FY2026 Q1, the actual value is USD 0.55, missing the estimate of USD 0.6947.EBIT: As of FY2026 Q1, the actual value is USD 34.77 M.<h4>Net Product Revenue</h4>Harmony Biosciences Holdings, Inc. reported net product revenue of $215.4 million for the first quarter ended March 31, 2026, marking a 17% year-over-year increase compared to $184.7 million for the same period in 2025 .<h4>Cost of Product Sold</h4>Cost of product sold for Q1 2026 was $44.5 million, or 20.7% of net product revenue, an increase from $32.0 million, or 17.3%, for Q1 2025, representing a 39% increase year-over-year . This increase was primarily due to new royalties related to the Novitium License Agreement .<h4>Gross Profit</h4>Gross profit for the first quarter of 2026 was $170.875 million, compared to $152.739 million for the same period in 2025 .<h4>Operating Expenses</h4>Research and Development (R&amp;D) expenses were $69.4 million in Q1 2026, a 101% increase from $34.5 million in Q1 2025, primarily due to $32.0 million in up-front payments for license agreements and IPR&amp;D charges . Sales and Marketing expenses increased by 3% to $31.7 million in Q1 2026, from $30.7 million in Q1 2025 . General and Administrative (G&amp;A) expenses rose by 4% to $32.5 million in Q1 2026, from $31.2 million in Q1 2025 . Total Operating Expenses for Q1 2026 were $133.6 million, a 38% increase from $96.5 million in Q1 2025 . Without IPR&amp;D charges, operating expenses would have increased by a modest 5% .<h4>Operating Income</h4>Operating income for Q1 2026 was $37.291 million, compared to $56.245 million for Q1 2025 .<h4>Other Income/Expense and Interest</h4>Other (expense) income, net, was - $127 thousand in Q1 2026, compared to - $276 thousand in Q1 2025 . Interest expense was - $3,234 thousand in Q1 2026, down from - $3,836 thousand in Q1 2025 . Interest income was $5,757 thousand in Q1 2026, up from $5,044 thousand in Q1 2025 .<h4>Net Income</h4>Net income for Q1 2026 was $32.5 million, a -29% decrease from $45.6 million in Q1 2025, primarily due to licensing agreements .<h4>Comprehensive Income</h4>Comprehensive income for Q1 2026 was $31.729 million, compared to $45.739 million for Q1 2025 . Unrealized (loss) income on investments was - $759 thousand in Q1 2026, compared to $179 thousand in Q1 2025 .<h4>Cash, Cash Equivalents, and Investments</h4>As of March 31, 2026, Harmony Biosciences Holdings, Inc. had cash, cash equivalents, and investments totaling $870.5 million, a decrease from $882.5 million as of December 31, 2025 . This reduction was mainly attributed to upfront payments for license agreements and ANDA settlements during Q1 2026, which also muted cash generation . As of Q1 2026, this represented a 43% increase from $610.2 million in Q1 2025 .<h4>Operational Metrics</h4>The average number of patients for WAKIX in Q1 2026 was 8,500, with the quarter exiting at an average of 8,600 patients . The company observed a 17% quarter-over-quarter revenue growth and added over 400 patients for the first time after three consecutive quarters of record growth .<h4>Outlook and Guidance</h4>Harmony Biosciences Holdings, Inc. reiterated its full-year 2026 net revenue guidance for WAKIX between $1.0 billion and $1.04 billion . The company anticipates filing the New Drug Application (NDA) for Pitolisant GR in Q2 2026, with a projected PDUFA date in Q1 2027 . Topline data for Pitolisant HD Phase 3 trials and EPX-100 are expected in 2027 and 1H 2027, respectively, with anticipated PDUFA dates in 2028 . Phase 3 topline data for Pitolisant in Prader-Willi Syndrome (PWS) is expected in 2H 2026, and Phase 1 clinical PK data for BP-205 is on track for mid-2026, with a U.S. IND submission for BP-205 also planned for mid-2026 .

Harmony Biosciences | 8-K: FY2026 Q1 Revenue Misses Estimate at USD 215.39 M